Table 2 Clinical Trials ongoing in mCRC of immune-checkpoint inhibitors as single agents or in combination with chemotherapy
Drugs | Trial | Setting | MSI/MSS status population | Primary Endpoint |
|---|---|---|---|---|
Nivolumab + standard therapy vs standard therapy [26] | CheckMate 9X8 NCT03414983 Phase II/III | 1 L | unselected | PFS |
Nivolumab alone Nivolumab in combination with other drugs [27] | CheckMate 142 NCT02060188 Phase II | 1 L | MSI/MSS | ORR by investigators |
Nivolumab + Ipilimumab + Temozolomide [28] | NCT03832621 Phase II | 1 L | MSS MGMT silenced | 8-months PFS |
Nivolumab Nivolumab + Ipilimumab or standard therapy [29] | NCT04008030 Phase III | 1 L | MSI-H/MMRd | PFS |
Pembrolizumab vs standard therapy [30] | KEYNOTE-177 NCT02563002 Phase III | 1 L | MSI-H/MMRd | PFS, OS |
Pembrolizumab + pemetrexed and oxaliplatin [31] | NCT03626992 Phase Ib | 2 L+ | MSS | ORR |
Atezolizumab vs atezolizumab + FOLFOX/bevacizumab vs FOLFOX/bevacizumab [32] | COMMIT GI004/S1610 NCT02997228 Phase III | 1 L | MMRd | PFS |
Avelumab [33] | NCT03150706 Phase II | 2 L+ | MSI-H/MMRd POLE | ORR |
Avelumab vs standard chemotherapy +/− targeted therapy [34] | NCT03186326 Phase II | 2 L | MSI | PFS by central review |
Durvalumab [35] | NCT02227667 Phase II | 3 L+ | MSI-I/MMRd | best response rate |
Durvalumab [36] | NCT03435107 Phase II | 2 L | MSI/MMRd POLE | ORR |
Durvalumab plus tremelimumab + FOLFOX [37] | NCT03202758 Phase Ib/II | 1 L | unselected | safety, PFS |